GELSOFT

Additional Manufacturer Narrative

THE SITE ADVISED THAT THE DEVICE IS NOT AVAILABLE; THEREFORE NO EVALUATION OF THE GRAFT WAS POSSIBLE. (B)(4). ANALYSIS OF PRODUCTION RECORDS - A REVIEW OF THE RETAINED QC AND MANUFACTURING RECORDS FOR THIS BATCH (WITH ATTENTION TO ALL IN PROCESS AND BASE MATERIAL POROSITY TESTING) CONFIRMED THAT THE BATCH WAS MANUFACTURED TO ITS DESIGN SPECIFICATION. TREND ANALYSIS - REVIEW OF SIMILAR COMPLAINTS OF LEAKAGE FOR ALL GELSOFT BRANDED DEVICES GAVE AN OCCURRENCE RATE OF (B)(4). COMMUNICATION/INTERVIEWS - ADDITIONAL INFORMATION WAS REQUESTED/RECEIVED FROM THE CLINICIAN REGARDING THE PROCEDURE. THIS INFORMATION CONFIRMED THAT THE CLINICIAN USED THE DEVICE AS PER IFU GUIDELINES. DEVICE NOT RETURNED - THE SITE ADVISED THAT THE DEVICE IS NOT AVAILABLE. NO DEVICE PROBLEM FOUND - NO ISSUE WAS FOUND WITH THE MANUFACTURING OF THE BATCH (BASED ON THE REVIEW OF THE RETAINED PRODUCTION RECORDS) CAUSE NOT ESTABLISHED - THE ROOT CAUSE OF THE REPORTED DEFECT COULD NOT BE DETERMINED. VASCUTEK LTD. CONSIDERS THIS EVENT AS CLOSED. FURTHER ACTION IS NOT PLANNED, HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ON-GOING COMPLAINTS TRENDING AND REPORTING PROCESS, IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME.

Description of Event or Problem

VASCUTEK LTD'S DISTRIBUTOR IN (B)(4) REPORTED THAT DURING A PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM WITH A GELSOFT BIFURCATE DEVICE ON (B)(6) 2021, THE IMPLANTING CLINICIAN REPORTED BLOOD LEAKAGE AT THE BIFURCATION AND LIMB AREAS. THE LEAK SITES WERE ARRESTED BY PLACEMENT OF SUTURES. THE PATIENT SUFFERED NO HARM OR INJURY.